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Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol Levels — SOS  

HIV Clinical Trial

Official title:
Rosuvastatin Versus Protease Inhibitor Switching for Hypercholesterolaemia in HIV-infected Adults

Clinical Trial Summary

To compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks.

Clinical Trial Description

To compare the effects of rosuvastatin to protease inhibitor switching on:

- Total cholesterol through week 12

- Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy)

- Quality of life (SF-12)

- Fasting LDL cholesterol (estimated with Friedewald equation unless triglycerides >400mg/dL, in which case LDL-C would be measured directly), HDL cholesterol, total : HDL cholesterol ratio, LDL particles sizes, triglycerides

- Fasting glucose and insulin

- Framingham cardiovascular risk score

- D:A:D 5-year estimated risk calculator ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01935674
Study type Interventional
Source Hospital Clinic of Barcelona
Contact
Status Completed
Phase Phase 4
Start date September 2013
Completion date September 2014
View Details
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